MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES

Model Number	W2-10-5-MVI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Thrombosis/Thrombus (4440)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a web device was implanted in an aneurysm of the basilar artery on (b)(6) 2023.On october 11, 2023, the patient experienced right sided vision loss due to thrombus located on the left p1 segment of the posterior cerebral artery.The patient was given emergent integrilin overnight and he recovered.The web was protruding, but less than 20% and not occlusive.No stroke was observed on mri at that point.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient was not available for evaluation.Fluoroscopic images were provided and are currently being reviewed.A supplemental report will be submitted after the investigation is completed.
Additional Manufacturer Narrative
The reported event is non-verifiable.Four radiographic images were provided for review.They are not labeled as to time/date.The review of the images is as followed: (b)(6) image 1: coned down and magnified ap skull radiograph, no contrast: an expanded web is seen (presumably in the basilar tip aneurysm).Two measurement lines are seen horizontally through the web (x1, x2), but the measurements in mm have not been included on the image.The web is still attached to the pusher and the via catheter tip is at the level of the web¿s proximal marker.There is some mild stretching of the base of the web.(b)(6) image 2: lateral subtracted basilar dsa, with barely visible contrast material.The base of the web is moderately invaginated.The web is detached and the via is now in the distal basilar, away from the web¿s proximal marker.A dac is seen in the mid-basilar.There is not enough contrast to determine if there is clot or if the web is encroaching on either p1.(b)(6) image 3: lateral unsubtracted basilar radiograph, with no contrast material.Same findings as in image 2.(b)(6) image 4: ap unsubtracted basilar radiograph, with no contrast material.Same findings as in image 3.These images do not explain why clot formed in the left p1.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.
Event or Problem Description
It was reported that a web device was implanted in an aneurysm of the basilar artery on (b)(6) 2023.On (b)(6) 2023, the patient experienced right sided vision loss due to thrombus located on the left p1 segment of the posterior cerebral artery.The patient was given emergent integrilin overnight and he recovered.The web was protruding, but less than 20% and not occlusive.No stroke was observed on mri at that point.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92620
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18025204
• Report Number: 2032493-2023-01014
• Device Sequence Number: 12651596
• Product Code: OPR
• UDI-Device Identifier: 00842429107256
• UDI-Public: (01)00842429107256(11)220330(17)270228(10)0000174078
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: W2-10-5-MVI-3
• Device Lot Number: 0000174078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 88 KG